Antibiotics: what they are, when they are prescribed and why they are not taken “on demand”

Pe scurt: A complete guide to antibiotics in Romania: classes, active substances, usual doses, ANMDMR regulation, CNAS reimbursement, bacterial resistance and common mistakes.

Antibiotics radically changed 20th-century medicine, but their overuse in Romania consistently places the country at the top of the European charts for bacterial resistance. According to ECDC data and the National Centre for the Surveillance of Communicable Diseases (CNSBT-INSP), in 2023 Romania had one of the highest outpatient consumption rates in the EU, measured in DDD (defined daily doses) per 1,000 inhabitants. Here is what antibiotics are, when they make sense, and why "an antibiotic for any flu" is a bad idea — not just for you, but for everyone around you.

What antibiotics are and what they act on

Antibiotics are molecules (natural, semi-synthetic or synthetic) that kill or stop the multiplication of bacteria. That is all. They do not act on viruses — the flu, the common cold, most sore throats, COVID-19, viral bronchiolitis in children. This is exactly where the biggest problem in the Romanian community pharmacy comes from: patients asking for "a strong antibiotic" for a flu-like state that an antibiotic does not treat in any way.

The mechanisms vary: beta-lactams (penicillins, cephalosporins) attack the bacterial cell wall; macrolides (azithromycin, clarithromycin) and tetracyclines (doxycycline) inhibit protein synthesis; fluoroquinolones (ciprofloxacin, levofloxacin) block bacterial DNA replication. Their spectra differ greatly — no antibiotic "covers everything".

Regulation in Romania: prescription required

According to the National Agency for Medicines (ANMDMR) and the updated Ministry of Health Order no. 369/2017, systemic antibiotics are classified as P-RF (prescription retained at the pharmacy) or PR (simple prescription). Dispensing without a prescription is punishable both for the pharmacist and for the pharmacy. On paper, things are clear. In practice, repeated audits (the latest inspections by the National Health Insurance House, CNAS) have shown regular breaches.

Many antibiotics are partially or fully reimbursed on the CNAS list — usually 50% on List C2, prescribed by a family doctor, pulmonologist, ENT specialist or paediatrician, depending on the indication. The exact list is checked on the CNAS portal or directly with the pharmacist; the maximum reference price is published in CANAMED, the catalogue updated periodically by the Ministry of Health.

The most common active substances on the Romanian market

Active substanceClassCommercial examplesTypical indication
AmoxicillinPenicillinOspamox, Amoxiplus, DuomoxOtitis, sinusitis, strep throat
Amoxicillin + clavulanic acidPenicillin + inhibitorAugmentin, Bioclavid, AmoksiklavPneumonia, skin infections
AzithromycinMacrolideSumamed, Azitrox, AzibiotAtypical pneumonia, penicillin allergy
CiprofloxacinFluoroquinoloneCiprinol, Ciplox, CiprobayComplicated urinary infections, prostatitis
DoxycyclineTetracyclineDoxiciclină Atb, VibramycinInflammatory acne, Lyme, atypicals
Cefuroxime axetil2nd-gen cephalosporinZinnat, AksefSinusitis, COPD exacerbations

Price and availability data vary between the Catena, Dona, Help Net, Farmacia Tei, Dr.Max, Mattca and Springfarma chains. Check the updated price on the product page in HartaFarmacii before you travel.

When you really need an antibiotic

The decision is the doctor's, but it helps to know the signs that point to a bacterial — not viral — infection:

  • Fever >38.5°C that persists beyond 3-4 days or rises again after falling (the classic biphasic pattern of superinfection).
  • Localised purulent secretions (yellow-green, opaque), unilateral pain — sinusitis, acute otitis media with suggestive otoscopy.
  • A positive test (for example a strep test for streptococcal pharyngitis, a urine culture for a UTI).
  • Suggestive imaging or labs: chest X-ray with pulmonary consolidation, CRP >40-50 mg/L, raised procalcitonin.

The BNF and EMA guidelines recommend empirical antibiotic therapy only where the bacterial probability is high enough and delay would be risky (community-acquired pneumonia, pyelonephritis, skin infection with cellulitis).

Doses, duration and adherence

Two major adherence mistakes surface in pharmacy counselling: stopping treatment "when I feel better" and skipping doses. Both increase the selection pressure for resistant strains. Modern WHO and BNF recommendations tend, in many indications, towards shorter courses (5 days instead of 10), but exactly as prescribed — no less, no more.

Common examples (indicative, not advice): amoxicillin 500 mg every 8 hours for uncomplicated respiratory infections, 5-7 days; azithromycin 500 mg/day for 3 days or the 500-250-250-250-250 mg schedule; doxycycline 100 mg twice a day; ciprofloxacin 500 mg every 12 hours for a complicated UTI. Adjustment in renal or hepatic impairment is done by the doctor.

Side effects worth discussing at the counter

  • Diarrhoea (more frequent with amoxicillin-clavulanate) — from mild discomfort to colitis with Clostridioides difficile. Probiotics such as Saccharomyces boulardii have moderate evidence for prevention.
  • Allergic reactions — from a rash to anaphylaxis. Self-reported "penicillin allergy" is overestimated: studies show that <10% of patients are truly allergic on testing.
  • Tendinopathy and rupture risk with fluoroquinolones (ciprofloxacin, levofloxacin) — an official warning published by ANMDMR, per the European SmPC.
  • Photosensitivity with doxycycline and fluoroquinolones — avoid prolonged sun exposure.
  • Interactions — macrolides with statins (myopathy risk), tetracyclines with calcium/iron/dairy (chelation, reduced absorption).

Frequently asked questions

Can I take a "leftover" antibiotic from another infection?
No. The dose, spectrum and duration are chosen for a specific infection. Recycling creates resistant strains and masks symptoms.
If I feel better in 2 days, can I stop the treatment?
No. You take the full course, exactly as the doctor prescribed it.
Do antibiotics "cut" the effect of oral contraceptives?
For most antibiotics, current evidence (BNF, EMA) does not confirm a clinically significant reduction, except for rifampicin and rifabutin. Severe diarrhoea may still reduce absorption.
Can I drink alcohol during treatment?
With metronidazole and tinidazole — strictly forbidden (disulfiram-like reaction). With most other antibiotics, alcohol does not interact directly, but it loads your liver and prolongs recovery.
Why won't my doctor give me an antibiotic for every cough?
Because most coughs (90%+) are viral. The antibiotic does not help; it destroys your microbiota and feeds resistance instead.
What is "antibiotic resistance", really?
The ability of bacteria to survive a treatment that would normally kill them. It arises through selection: if you take antibiotics often, poorly or incompletely, the more resistant strains survive.
Can I buy an antibiotic without a prescription in Romania?
Legally, no. Dispensing without a prescription is a disciplinary offence for the pharmacist and is punishable for the pharmacy.

How the empirical choice between classes is made

In outpatient medicine, the first 24-48 hours are often treated empirically, before a culture is available. Here is how a well-trained physician reasons, in line with the protocols of the Romanian Society of Infectious Diseases and the IDSA/BNF guidelines:

  • Streptococcal pharyngitis (fever, tonsillar exudate, cervical adenopathy, no cough — Centor score ≥3): amoxicillin 500 mg three times a day for 10 days, or penicillin V; alternative in allergy — azithromycin.
  • Acute otitis media in children: amoxicillin 80 mg/kg/day or amoxicillin-clavulanate if an antibiotic was given in the last 30 days.
  • Acute bacterial sinusitis: amoxicillin-clavulanate 875/125 mg twice a day, 5-7 days.
  • Uncomplicated community-acquired pneumonia: amoxicillin 1000 mg every 8 hours or doxycycline 200 mg on day 1 then 100 mg/day; if atypicals are suspected (Mycoplasma) — azithromycin.
  • Acute uncomplicated cystitis in women: nitrofurantoin 100 mg four times a day or fosfomycin 3 g single dose; trimethoprim only where local resistance is <20%.
  • Outpatient pyelonephritis: ciprofloxacin 500 mg twice a day for 7 days or cefuroxime axetil — adjusted after the urine culture.
  • Erysipelas/cellulitis: amoxicillin-clavulanate or cephalexin; if MRSA is suspected — clindamycin or trimethoprim-sulfamethoxazole.

These schemes are indicative and are adjusted to local resistance, renal/ hepatic function, pregnancy, allergies and interactions — the main reason the decision stays strictly with the prescribing physician.

The gut microbiota: what happens behind the curtain

An antibiotic course affects not only the target pathogen but also the normal flora — especially in the colon. Studies using 16S sequencing have shown reductions in microbial diversity detectable for months after a single course. Recovery varies between patients and is slower with frequent repetitions.

Practical consequences: antibiotic-associated diarrhoea, opportunistic overgrowth (Clostridioides difficile, Candida), sometimes post-antibiotic irritable bowel syndrome. Recommendations:

  • A dedicated probiotic — Saccharomyces boulardii (Enterol) or Lactobacillus rhamnosus GG, a daily dose throughout the course and for 1-2 weeks afterwards.
  • Adequate hydration, a diet with soluble and fermented fibres (yoghurt, kefir).
  • A 2-hour gap between taking the antibiotic and the probiotic.

Costs and access in Romania

Price differences between chains are real: a box of Augmentin BD 875/125 mg can vary by 15-20 lei between Catena, Dona, Help Net, Farmacia Tei, Dr.Max, Mattca and Springfarma. For the chronic patient (for example, doxycycline 100 mg for months in severe acne), the annual saving easily exceeds 200 lei. Comparing on HartaFarmacii before buying makes economic sense especially for long courses prescribed by a dermatologist or family doctor.

For patients without CNAS insurance or with non-reimbursed prescriptions, Romanian generics (Terapia Cluj, Antibiotice Iași, Labormed-Alvogen) cost, on average, 30-50% less than the originator brand for the same molecule and strength. Bioequivalence is guaranteed by ANMDMR through bioequivalence studies required at authorisation.

Sources

  • ANMDMR — Summaries of Product Characteristics (anm.ro)
  • CNAS — reimbursed medicines lists (cnas.ro)
  • Ministry of Health — CANAMED, monthly updated catalogue
  • EMA — antimicrobial resistance assessment reports
  • WHO — Antimicrobial resistance fact sheet
  • British National Formulary (BNF) — antibacterial use guidelines
  • ECDC — European Antimicrobial Resistance Surveillance Network (EARS-Net)
  • IDSA — Infectious Diseases Society of America practice guidelines
  • Romanian Society of Infectious Diseases — therapeutic protocols